overview of 2020 chemical data reporting (cdr) · 2019-09-25 · background: epa uses of the cdr...

Overview of 2020 Chemical Data Reporting (CDR)

SOCMA Policy Summit September 17, 2019

1U.S. Environmental Protection Agency

Presentation Overview• CDR Background• 2020 Reporting Requirements (Including

proposed changes) • Proposed TSCA§8(a)

Small Manufacturing Definition Update• Non-Regulatory Updates • Additional Information


Background: Chemical Data Reporting (CDR)• CDR is a collection of basic exposure-related information on the

types, quantities, and uses of chemical substances manufactured domestically or imported into the United States– Chemical substances listed on the TSCA Inventory– Certain classes of chemicals, such as polymers, are exempted from

reporting• Information is submitted every four years

– Most recently submitted in 2016, covering calendar years 2012-2015– Next submission period is in 2020, covering calendar years 2016-2019

• The reporting threshold is 25,000 pounds per site or 2,500 pounds for chemical substances subject to certain TSCA actions

• In 2016, about 5,660 sites reported approximately 8,700 chemicals, resulting in close to 42,500 chemical reports


Background on Proposed Rule: TSCA Section 8(a) Chemical Data Reporting Revisions and Small

Manufacturer Definition Update • Proposed April 24, 2019 • Goals of the proposed CDR Revisions:

– Make regulatory updates to align with new statutory requirements of TSCA

– Improve the CDR data as necessary to support the implementation of TSCA

– Reduce burden for certain CDR reporters• Comment Period ended June 24, 2019; 24 public comments

received • Regulations.gov docket: EPA-HQ-OPPT-2018-0321• To be finalized Winter 2019-2020


Background: EPA Uses of the CDR Data• Office of Chemical Safety and Pollution Prevention

– Chemical screening and prioritization process– Risk evaluation– OECD Emission Scenario Documents (ESD)/generic scenario

development– Insight on production volume trends of chemicals

• Other EPA Offices (e.g., Office of Research and Development and Office of Water)– Life cycle assessments– Standardized emission evaluations– Chemical and industry sector prioritization– Industry characterization


Background: Other Uses of the CDR Data• Users include other Federal government

organizations, state governments, the public, NGOs, and industry

• Examples:– State OSHA/worker health and safety– Facility siting and permitting (such as air and water permits)– Compliance and enforcement for disposal, releases, or

mismanagement– Legacy site cleanup (informing future activities)


2020 Reporting Requirements (Including

Proposed Changes)


Overview of 2020 CDR Requirements

• When: The submission period is June 1 to September 30, 2020

• Who: Manufacturers, including importers, of chemical substances that:o Are listed on the TSCA Inventory as of June 1, 2020

− Have a production volume of 25,000 lbs or greater at a site in at least one of the years 2016-2019

o Unless subject to certain TSCA regulatory actions− Have a production volume of 2,500 lbs or greater

o Are not eligible for a full exemption from CDR


Overview of 2020 CDR Requirements• What: Submitters must report for each chemical substance at a single site:

– Annual production volume for 2016-2019– Certain manufacturing information for 2019– Processing and use information for 2019– Exemptions may reduce reporting (new exemptions are proposed)

• How: Submitters are required to report electronically• Where: Submitters report through EPA’s Central Data Exchange (CDX)

– Register with CDX – Access e-CDRweb, the CDR reporting tool – Create and submit a separate Form U for each site– Submit completed Form U following instructions in e-CDRweb


Important to Know

• Reporting is site-specific:– One Form U per site– One or more chemical substance reports on each

Form U• Reporting standard is “known to or

reasonably ascertainable by” for all data


Important to Know: Confidentiality Claims• Current CDR Regulation:

– Confidentiality claims must be made at the time the information is submitted– Upfront substantiation required for claims for selected data elements

• TSCA amendments (June 2016) required substantiation for most confidentiality claims• Proposed Changes

– Upfront substantiation would be required for all claims of confidentiality at the time they are made, except for:

• Production volume • Supplier identity, trade name, and formulation information associated with joint

submissions– EPA proposed updated substantiation questions and certification statement– General use data elements cannot be claimed as confidential

• Industrial: type of processing and use, industrial sectors, functions• Commercial/Consumer: product categories, functions, whether consumer or

commercial, whether intended for use by children


What is Reported? Site Identification Information • Highest level U.S. parent company and, if applicable, the foreign parent

company – Company name and address (Following the naming convention in 40 CFR

711.35) – Company Dun & Bradstreet number

• Manufacturing (including importing) site– Site name and address– Site Dun & Bradstreet number– Importers must report a U.S. address for the site– NAICS code for the site of manufacturer

• Technical contact(s) information– Name and address– Telephone number and email address

• (Voluntary) Public Contact – Name, phone number and email address 12

U.S. Environmental Protection Agency

What is Reported? Manufacturing-Related Data • Chemical Identity

– CASRN and Chemical Name – Accession Number and Generic Chemical Name for CBI substances

• Production Volume (PV) Related- – substantiation provided at submission

• Number of workers that are reasonably likely to be exposed (in ranges)• Maximum concentration• Physical form and percent production volume in the form• Indication of whether a chemical is recycled instead of being treated as a waste• The percent production volume that is a byproduct 13


What is Reported? Processing- and Use-Related Data • Required for production volumes of 25,000 lbs or more, at a site, unless subject to a

reduced threshold of 2,500 lbs more at a site, unless otherwise exempted • Industrial Processing and Use

14

• EPA proposed two changes:• Replace the CDR “industrial function and commercial/consumer product” use codes

with “OECD-based function, product, and article use categories;”• Add a new requirement to report function categories for commercial/consumer products

• Consumer and Commercial Use


ImportersImporters are subject to CDR• Under TSCA, manufacture includes import• If two or more persons meet the “importer” definition, they may determine who

will report (but both are liable)• Site is defined for importers in 40 CFR 711.3

– U.S. site of the unit directly responsible for importing– Must be a U.S. address, even if it is for an agent acting for the importer

• An importer will indicate whether each imported chemical is never physically present at the reporting site

• If a mixture is imported, the importer reports the individual chemical components of the mixture, including the percent composition– A joint submission with the supplier is used when the chemical identity or

mixture composition is unknown– The secondary submitter of a joint submission reports the function of the

chemical within the mixture • Imported articles are exempt under 40 CFR 711.10(b) 15


Identifying Your Imported Chemical Substance:• Sources of composition information include:

– MSDS or SDS– Supplier provided composition information

• If composition information claimed as confidential– Ask your supplier to provide the information directly to EPA– Both the primary and secondary submitters are able to identify parts of their

submission as confidential • Use known or reasonably ascertainable information to determine whether your

production volume triggers reporting– Overall production volume for imported mixture(s)– Available composition information from MSDS or SDS– Ask your supplier


Co-Manufactured Chemicals: Proposed Procedure

• Contracting company initiates the co-manufactured chemical report and notifies the producing company using the e-CDRweb reporting tool

• Proposed reporting responsibilities:


Overview of Proposed Reduced Requirements for Byproduct Reporting

• Proposed changes to CDR rule:– Allow Category Reporting for Inorganic Metal

Byproducts– Exempt Certain Byproduct Substances from

Selected Industries– Exempt Byproducts Manufactured in Certain Non-

Integral Equipment


Byproducts: Proposed Alternative Reporting• Current reporting: Chemical identity as listed on the TSCA

Inventory• Proposed alternative: Report inorganic metal byproducts in

specified categories as another option to current reporting


Proposed Exemption for Certain Byproduct Substances from Selected Industries

• EPA proposed to exempt specifically listed byproducts that are recycled in a site-limited manner when: – Recycled or used in physically enclosed systems; and– Remains on site; and– Site is reporting the byproduct substance or another substance

from the same overall manufacturing process• Proposed industries and byproducts for exemption are:

– Portland Cement manufacturing: cement kiln dust – Kraft pulping cycle: black liquor and calcium carbonate

• Proposed to add petition process to identify additional industries and byproducts


Proposed Process to add Industries and Byproducts

Proposal: Allow for a petition process to change the list of exempted byproducts from selected industries: • Is the byproduct recycled or otherwise used

– to manufacture another chemical substance within an enclosed system,

– within the same overall manufacturing process, and – on the same site as that byproduct was originally manufactured?

• Is the site reporting a different chemical substance that was manufactured from the byproduct or in the same overall manufacturing process?

• Does EPA have a current interest in the byproduct? 21


Proposed Exemption for Byproducts Manufactured in Non-Integral Equipment

Proposal: Exempt byproducts that are generated in equipment that is not chemically integral to the production process; specifically, pollution control and boiler equipment

22

An integral process is the portion of the manufacturing process that is chemically necessary or provides primary operational support for the production of the intended product.


Integral vs. Non-Integral Equipment• Equipment likely to be integral to the production process:

– Utilities using boilers to produce electricity as a product– Reverberatory furnaces used for smelting as part of production

process• Equipment likely to be non-integral to the production

process:– A site uses boilers to produce heat or electricity for their building but

does not produce the heat or electricity as a product– Flue gas desulfurization and selective catalytic reduction systems– Manufacturer produces a byproduct while treating wastewater from

cleaning tanks from their production process


Proposed TSCA§8(a)Small Manufacturing

Definition Update


TSCA§8(a) Small Manufacturing: Background

• During early implementation of TSCA (1970s), EPA took a case-by-case approach to definitions

• Small Manufacturer definitions under TSCA 8(a) were standardized on November 16, 1984 (49 FR 45425) and have not been changed

• Lautenberg Act required that EPA review the adequacy of the small manufacturing standards and determine if they warranted revision

• On November 30, 2017, EPA determined that revision of the definition and associated standards is warranted (82 FR 56824)


Rules using General 8(a) Small Manufacturing Definition

• Multi-chemicals rules:– 40 CFR 711 (CDR)– 40 CFR 412.25 (PAIR)

• Chemical-specific rules:– 40 CFR 704.25 (11-Aminoundecanoic acid)– 40 CFR 704.33 (P-tert-butylbenzoic acid (P-TBBA), p-tert-butyltoluene

(P-TBT) and p-tert-butylbenzaldehyde (P-TBB)) – 40 CFR 704.45 (Chlorinated terphenyl)– 40 CFR 704.95 (Phosphonic acid, [1,2-ethanediyl-bis[nitrilobis-

(methylene)]]tetrakis- (EDTMPA) and its salts)– 40 CFR 704.104 (Hexafluoropropylene oxide)– 40 CFR 704.175 (4,4′-methylenebis(2-chloroaniline) (MBOCA))


Small Manufacturer: Proposed Definition • Proposed: A small manufacturer would meet one of the following

– First standard: Total annual sales <$110 million and annual PV ≤ 100,000 lbs at a site

• Reporting is required for any sites where annual PV > 100,000 lbs ; OR

– Second Standard: Total annual sales <$11 million, regardless of PV

• Total annual sales means annual sales of submitter combined with a parent company, domestic or foreign (if any)

• Asked for comment on alternate definitions– An employment-based size standard varied by industry, or – A combination of employment-based and revenue-based varied by

industry, such as the SBA standard with a 50,000 lbs production volume modifier


Planned Non-Regulatory Updates


Non-Regulatory Updates• Planned IT Enhancements

– New application platform resulting in better functionality and less lag and faster validations

– Application-integrated CBI substantiations– Streamlined CBI substantiations

• Potential Functionality– Improving uploading data:

• XML upload failure explanations• Spreadsheet (CSV file) upload enabled

– Auto-filling submission data from 2016 submissions to reduce time completing electronic submission


e-CDRweb Management and User Roles


New function to improve CDR reporting process

Non-Regulatory Updates

• Prior to 2020 reporting period, EPA plans to: – Conduct beta testing of reporting tool in Winter

2020– Host public guidance webinars covering:

• e-CDRweb reporting tool • Reporting requirements • Topic-specific new reporting requirements


More Information • www.regulations.gov: EPA-HQ-OPPT-2018-0321

– Instructions for Reporting- 2020 TSCA Chemical Data Reporting –Draft for Public Comment

– CDR Revisions eCDRweb Mockups – Technical Support Document – Harmonizing CDR Functional and

Product Codes with OECD Functional Product and Article Codes – Proposed Optional Reporting in Metal Categories for Inorganic

Byproducts • www.epa.gov/CDR

– EPA will post updated information as it is developed– Send reporting-related questions to [email protected]


http://www.regulations.gov/

http://www.epa.gov/CDR

Projected Schedule

• Publication of Proposed Rule: April 2019• Publication of Final Rule: January 2020• e-CDRweb reporting tool in compliance with

regulatory changes– Beta-testing: November 2019– Full deployment: March 2020

• Next CDR submission period opens: June 1, 2020 and closes: September 30, 2020
